Effects on Quality of Life With Zinc Supplementation in Patients With Gastrointestinal Cancer
NCT ID: NCT03819088
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2019-04-17
2022-03-22
Brief Summary
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Detailed Description
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I. Assess the effects on quality of life (QOL) when supplementing zinc in upper gastrointestinal (GI) cancer patients while they are receiving chemotherapy.
SECONDARY OBJECTIVES:
I. Correlate hypoalbuminemia with serum zinc deficiency.
II. Correlate zinc deficiency with neutropenia.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients receive zinc orally (PO) thrice daily (TID) for months 1 and 2 only of the first 4 months on therapy.
GROUP II: Patients receive zinc orally (PO) TID for months 3 and 4 only of the first 4 months on therapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group I (zinc months 1 and 2)
Patients receive zinc PO TID for months 1 and 2 only of the first 4 months on therapy.
Zinc
Given PO
Group II (zinc months 3 and 4)
Patients receive zinc PO TID for months 3 and 4 only of the first 4 months on therapy.
Zinc
Given PO
Interventions
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Zinc
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients plan to receive chemotherapy at an Emory Cancer Center
* No prior chemotherapy or radiation therapy for newly diagnosed gastric, gastro-esophageal, pancreas or biliary cancer
* Patients must sign informed consent
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Institutes of Health (NIH)
NIH
Emory University
OTHER
Responsible Party
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Olatunji Alese
Principal Investigator
Principal Investigators
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Olatunji B. Alese, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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NCI-2017-02467
Identifier Type: REGISTRY
Identifier Source: secondary_id
Winship4173-17
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00099791
Identifier Type: -
Identifier Source: org_study_id
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